Buprenorphine HIV Care Integration Project - Tabular View

Tracking Information

First Received Date ^ICMJE

July 5, 2006

Last Updated Date

March 14, 2008

Start Date ^ICMJE

July 2006

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence [ Time Frame: week 48 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence

Change History

Complete list of historical versions of study NCT00348868 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Buprenorphine HIV Care Integration Project

Official Title ^ICMJE

Miami Buprenorphine HIV Care Integration Project

Brief Summary

A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.

Detailed Description

DESIGN: A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.

DURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years.

SAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks.

POPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection.

STRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care)

INTERVENTON At entry subjects will be randomized to one of the following:

ARM A: Standard drug addiction counseling + buprenorphine / naloxone

ARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone

The three primary outcomes are:

Cessation of illicit opioid use
Reduction in high risk behavior
Improved HIV therapy adherence

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

HIV Infection
Opioid-Related Disorders

Intervention ^ICMJE

Behavioral: enhanced behavioral motivation counseling
Behavioral: Motivational counseling
Behavioral: Standard counseling

Study Arms / Comparison Groups

Experimental: enhanced behavioral motivation counseling

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

HIV infection
Receiving or seeking outpatient HIV care
Seeking outpatient treatment for opioid dependence and be willing to take buprenorphine
Meets DSM-IV criteria for opioid dependence, and be willing to stop illicit opioid use and be experiencing early symptoms of opioid withdrawal at the time that buprenorphine is given
Men and women age ≥ 18 years
Women of reproductive potential must have a negative serum or urine pregnancy test result available within 7 days prior to initiating buprenorphine
Within 30 days: (SGOT), ALT (SGPT), and alkaline phosphatase <=5 X ULN, Total bilirubin <= 2.5 x ULN

Exclusion Criteria:

Serious medical problem
Acute and/or severe psychiatric conditions
High dose methadone (>30 mg/day)
Documented co-dependence on alcohol and/or benzodiazepines, barbiturates
Chronic pain management requiring opioids
Pregnancy or breast-feeding
Imprisonment or involuntary incarceration in a medical facility for psychiatric or physical

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00348868

Responsible Party

Margaret A. Fischl, M.D., Unversity of Miami

Study ID Numbers ^ICMJE

A007

Study Sponsor ^ICMJE

University of Miami

Collaborators ^ICMJE

HRSA/Maternal and Child Health Bureau
National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Principal Investigator:

Margaret Fischl, M.D.

University of Miami

Information Provided By

University of Miami

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP